Catalyst Pharmaceuticals, a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, has reported financial results for the third quarter and nine months ended September 30, 2016 and provided a corporate update.
For the quarter ended September 30, 2016, Catalyst reported a GAAP net loss of $3,953,981 or 5 cents per basic and diluted share, compared to a GAAP net loss of $4,449,038 or 5 cents per basic and diluted share, for the same period in 2015.
For the nine months ended September 30, 2016, Catalyst reported a GAAP net loss of $13,909,132 or 17 cents per basic and diluted share, compared to a GAAP net loss of $14,417,800 or 18 cents per basic and diluted share, for the same period in 2015.
Patrick J. McEnany, Chief Executive Officer of Catalyst stated: “Over the last few months, we have continued to execute our development strategy for Firdapse® (amifampridine phosphate) and further our mission to serve the LEMS and CMS patient communities. We were pleased by our recent receipt of a Special Protocol Assessment agreement with the FDA for the protocol design, clinical endpoints, and statistical analysis approach to be taken in our upcoming, second Phase 3 study evaluating Firdapse for the symptomatic treatment of LEMS. We believe that our receipt of the SPA provides us with a clearly defined development and regulatory pathway to complete the development of this product. We were also gratified to have been granted orphan drug designation for Firdapse for the treatment of myasthenia gravis. Finally, we have launched our new website to make it easier for patients to access information about obtaining Firdapse at no cost through our expanded access program, which is another step in our continuing efforts to serve LEMS and CMS patients.”